MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER MULTI-FENESTRATED SEPTAL OCCLUDER - CRIBRIFORM; TRANSCATHETER SEPTAL OCCLUDER

Catalog Number 9-ASD-MF-030

Device Problem Difficult to Fold, Unfold or Collapse (1254)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/29/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that a 30mm amplatzer multi-fenestrated septal occluder - cribriform was selected for implant on (b)(6) 2023 using a 8f amplatzer trevisio intravascular delivery system.During implant both right and left discs took on a hamburger shape.The device was removed from the patient and replaced with a new 30mm amplatzer multi-fenestrated septal occluder - cribriform.There were no interactions with cardiac structures nor were there any angulations or kinks noted in the delivery system.During implant the right disc also took on a hamburger shape.The device was removed from the patient.There were no interactions with cardiac structures.The patient remained hemodynamically stable throughout the procedure.There were no clinically significant delays during the procedure.It was noted that the atrial septal defect was not closed due to the issue with the devices.There were no adverse effects to the patient.The patient status was noted as stable.

Manufacturer Narrative

An event of device deformity could not be confirmed.The device was returned to abbott for investigation and the device met functional specifications when analyzed under non-physiological conditions.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all defined manufacturing specifications.There were no complaints associated with any other devices from the lot.Information from the field indicated that there was no anatomical interference, or any angulation or kink in the delivery system upon deployment and 8f size delivery system was used.The cause of the reported incident could not be conclusively determined.

• Brand Name: AMPLATZER MULTI-FENESTRATED SEPTAL OCCLUDER - CRIBRIFORM
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG# 2135147; 5050 nathan ln n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18374834
• MDR Text Key: 331367726
• Report Number: 2135147-2023-05617
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806010304
• UDI-Public: 00811806010304
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: P000039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9-ASD-MF-030
• Device Lot Number: 8622684
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2023
• Initial Date FDA Received: 12/21/2023
• Supplement Dates Manufacturer Received: 01/15/2024
• Supplement Dates FDA Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: AMPLATZER TREVISIO INTRAVASCULAR DS, 9-ATV08F45/80.
• Patient Age: 31 YR
• Patient Weight: 71 KG